segunda-feira , 4 julho 2022
Capa » International News » European Commission withdraws MA for Pfizer’s Staquis, causing uncertainty for ‘mild to moderate’ AD treatment

European Commission withdraws MA for Pfizer’s Staquis, causing uncertainty for ‘mild to moderate’ AD treatment

says GlobalData 

The European Commission (EC) withdrew the marketing authorisation (MA) for Pfizer’s topical phosphodiesterase-4 (PDE4), Staquis (crisaborole) in the EU (known as Eucrisa in the US). This highlights a gap in the market for the treatment of ‘mild to moderate’ atopic dermatitis (AD), one that has yet to be filled by an effective topical therapy. Although Staquis was approved in March 2020, it was never launched in Europe, finds GlobalData, a leading data and analytics company.

Ramla Salad, Pharma Analyst at GlobalData, comments: “Eucrisa is not approved in Japan, but it has been widely used in the US following its approval in 2016 and is now used in patients as young as three months, which speaks volumes about its safety profile. However, Eucrisa is an expensive therapy, averaging at $3,000 per year for all mild to moderate age groups. This, along with its modest efficacy, may explain the reluctance to reimburse the drug in the EU when assessing the cost/benefit ratio.”

While Eucrisa/Staquis is losing traction in the EU and Japan, there are some new PDE4s being developed. These include Otsuka Pharmaceutical/Medimetriks’ Moizerto (difamilast), which was approved by Japan’s Pharmaceuticals and Medical Devices Agency in September 2021, and Arcutis Biotherapeutics’ roflumilast, which is in late-stage development and aiming to enter the atopic dermatitis (AD) market soon. Both PDE4 inhibitors have shown great efficacy profiles but have failed to completely address the onsite application pain experienced with Eucrisa.

Salad concludes: “Given this level of competition in the market, key opinion leaders (KOLs) interviewed by GlobalData noted that the PDE4 mechanism of action (MOA) is outdated due to the limited class efficacy in this disease. This is because it will be difficult for these agents to differentiate themselves from newer entrants, which includes market disruptors such as Dupixent and oral and topical JAK inhibitors.”

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